Our Expertise
ntegrow offers end-to-end regulatory services with strategic expertise for efficient lifecycle and data management operations, ensuring a faster go-to-market process. Our team of experienced regulatory professionals provides comprehensive support for products at all stages of development. We collaborate with companies to bring products to market in the most efficient and cost-effective manner, navigating the increasingly complex regulatory landscape.
To help make products available in target countries, our expert team ensures regulatory compliance across the globe. To simplify the integration of regulatory solutions, we adhere to three key principles:
- We speak the language of pharma.
- We work with pharma industry dossiers in standard formats, such as country-specific, ACTD, and CTD.
- We constantly monitor evolving regulations and adapt to changes accordingly.
What our Expert do ?
Tracking Region-Specific HA Regulations
- Quality and Assurance
- GxP Practices
- Audit and Validation
- Lifecycle Management
- Pharma CMC
- Dossier Compilation
Pharmaceutical Regulatory Affairs Procedural Complexities
- Publishing and Submission
- Dossier Preparation
- Labelling, Artwork Design, and Pack Management
- Medical Writing
Aligning with and Meeting Mandatory Deadlines
Our team ensures that all regulatory requirements and deadlines are met, facilitating a smooth and timely approval process.
Global Coverage
Our expert network and processes support registrations worldwide, utilizing standard pharma industry dossier formats suitable for each country. This global reach ensures that your products can be efficiently registered and brought to market in diverse regions.
Always Up-to-Date
We continuously monitor regulatory changes and assess their impact on registration requirements. This proactive approach allows us to adapt quickly to new regulations, minimizing potential delays and ensuring compliance.
Reliable Partner
Our best practices and proven track record guarantee that dossiers meet authority expectations. We work diligently to ensure that all submissions are accurate, comprehensive, and aligned with regulatory requirements.
Direct Contact
Our regulatory expert team is always available to address urgent authority inquiries. We provide direct and prompt communication to resolve any issues swiftly, ensuring a seamless regulatory process.